Label: NIGHTTIME SLEEP-AID- diphenhydramine hydrochloride liquid

  • NDC Code(s): 53942-522-28
  • Packager: DeMoulas Market Basket
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 29, 2023

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  • Active ingredientsDRUG FACTS(in each 30 mL dose cup or 2 tablespoons)

    Diphenhydramine HCL 50 mg

  • Purpose

    Nighttime sleep-aid

  • Keep out of reach of children

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Uses

    • reduces time to fall asleep if you have difficulty falling asleep
    • for relief of occassional sleeplessness
  • Warnings

    Do not use

    • for children under 12 years of age
    • with any other product containing diphenhydramine, even one used on skin
    • with any other drugs that cause drowsiness such as antihistamines and nighttime cough, cold/flu products
  • Ask a doctor before use if you have

    • heart disease
    • trouble urinating due to an enlarged prostate gland
    • glaucoma
    • a breathing problem such as asthma, emphysema or chronic bronchitis
  • Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers or any other sleep aid

  • When using this product

    • do not use more than directed
    • avoid alcoholic beverages and other drugs that cause drowsiness
    • drowsiness will occur
    • be careful when driving a motor vehicle or operating machinery
    • alcohol, sedatives, and tranquilizers may increase drowsiness
  • Stop use and ask a doctor if

    • sleepiness persists continuously for more than two weeks. Insomnia may be a symptom of a serious underlying medical illness.
  • If pregnant or breast feeding

    ask a health professional before use.

  • Other information

    • each 30 mL dose (2 tablespoons) contains: sodium 23 mg
    • dosage cup provided
    • store at room temperature
  • Inactive ingredients

    citric acid, FD and C Blue # 1, FD and C Red # 40, flavor, high fructose corn syrup, poloxamer 407, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin

  • Questions?

    Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

  • Directions

    • take only as recommended
    • use dosage cup or tablespoon

    Age                                                              Dose
    Adults and children 12 years and over             One dose = 2 tablespoons (30 mL) at bedtime if needed or as directed by a doctor

  • Product Label

    *COMPARE TO THE ACTIVE INGREDIENT IN ZzzQuil™ NIGHTTIME SLEEP-AID

    Nighttime

    SLEEP-AID

    Diphenhydramine

    Non-Habit Forming

    Warming Berry Flavored Liquid

    No for treating Cold or Flu

    12 FL OZ (354 mL)

    *This product is not manufactured or distributed by Proctor and Gamble, owner of the registered trademark ZzzQuil™ .

    DISTRIBUTED BY DEMOULAS SUPERMARKETS INC.

    875 EAST STREET

    TEWKSBURY, MA 01876

    LR-053 Rev 01

    DO NOT USE IF IMPRINT SHRINK BAND IS MISSING OR BROKEN

    Failure to follow these warnings could result in serious consequences

    AptaPharmMB Sleep Aid 522

    res

    AptaPharmMB Sleep Aid 522

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP-AID 
    diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53942-522
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53942-522-28354 mL in 1 BOTTLE; Type 0: Not a Combination Product09/19/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01009/19/2013
    Labeler - DeMoulas Market Basket (007869647)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(53942-522)
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